SOCRA CCRP Practice Exam

Who ultimately approves an ICF?

1. FDA

2. Sponsor

3. IRB

4. Principal Investigator

The correct answer is: IRB

An ICF, or Informed Consent Form, is an important document used in the clinical trial process. It outlines the important information that a participant needs to know before deciding to participate in a clinical trial, including potential risks and benefits. Ultimately, the party responsible for approving the ICF is the IRB, or Institutional Review Board. The FDA, or Food and Drug Administration, oversees the entire clinical trial process, but they do not have direct involvement in approving the ICF. The sponsor of the clinical trial may also be involved in reviewing and approving the ICF, but their role is primarily to provide the necessary resources and funding for the trial. The principal investigator is responsible for conducting the trial and obtaining informed consent from participants, but they are not the ultimate authority for approving the ICF. Therefore, the correct answer is C IRB.